Z-1992-2021Class II

HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)

Name: Z-1992-2021 HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Creator: Liebel-Flarsheim Company Llc
Published: 2021-03-11
License: https://open.fda.gov/license/

Mallinckrodt, Inc. / initiated 2021-03-11 / Terminated

FDA source

LIEBEL-FLARSHEIM COMPANY LLC began a recall of HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW) on 2021-03-11. FDA classified it as Class II and gives the reason as "Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than 35 percent. The dosage...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1992-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-11
Posted: 2021-07-02
Terminated: 2024-09-18
Recalling firm: Mallinckrodt, Inc.
Product: HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than 35 percent. The dosage displayed on the generator console and table display (monitor) is higher than the actual delivered dose.
FDA root cause: Radiation Control for Health and Safety Act
Action: The product can be brought into compliance via a software update. The firm plan to have the updated software installed, working with customer schedules, over the course of the next 12 months.
Quantity in commerce: 17
Distribution: US Nationwide Distribution and in the country of Canada
Product codes and lots: Product ID/Reorder Number: 705559 (65KW), 705560 (80KW) Model/NDC: HUTSHVDIS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1992-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1992-2021	Class II	Terminated	FDA Mandated	2021-07-14	2021-07-02

Product code MQB

K121838Class IILiebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim / cleared 2012-07-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)